Prognosticating Outcomes and Nudging Decisions With Electronic Records in the ICU Trial
- Conditions
- Critical Illness
- Interventions
- Behavioral: EHR-Based Intervention ABehavioral: EHR-Based Intervention B
- Registration Number
- NCT03139838
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that outcomes can be improved without raising costs by requiring intensive care unit clinicians to (i) document a prognostic estimate and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care. To test this hypothesis the investigators will conduct a 33-month trial at 17 intensive care units in 10 hospitals using the same Cerner EHR within Atrium Health System.
- Detailed Description
The PONDER-ICU trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The interventions are designed to increase intensive care unit (ICU) physicians' and advanced practitioners' (physician assistants and nurse practitioners) engagement of critically ill patients and caregivers in discussions about alternative treatment options, including care focused on comfort. To achieve this goal, the investigators will conduct a 33-month pragmatic, stepped-wedge cluster randomized clinical trial at 17 ICUs within 10 Atrium Health System hospitals. The investigators hypothesize that outcomes can be improved without raising costs by requiring ICU clinicians to (i) document a prognostic estimate (Intervention A) and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care (Intervention B). Approximately 4,750 adult patients (1) with chronic life-limiting illness and receiving continuous mechanical ventilation for ≥48 hours will be enrolled. Participating hospitals will be randomized into 5 clusters of 2 hospitals each. Each hospital will first contribute a minimum of 5 months of data collection during usual care in a control phase. Then, using the step-wedge design, all hospitals will implement the two EHR-based interventions. The order in which the interventions will be adopted and the timing of adoption at each hospital will both be determined by random assignment. After 12 months of utilizing Intervention A or Intervention B, each hospital will adopt and implement the second intervention in combination with the other. By the end of the trial, all hospitals will have utilized the combined interventions for at least 4 months. The primary outcome is a composite measure of hospital length of stay and mortality. Secondary outcomes include an array of clinical outcomes, as well as palliative care-related process measures.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3500
-
≥18 years old; AND
-
Admitted to 1 of the 17 participating ICUs; AND
-
Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
-
≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical history data from EHR in prior 12 months):
- Chronic obstructive pulmonary disease
- Cirrhosis
- Congestive heart failure
- Dementia (all types)
- End-stage renal disease
- Hematologic malignancy
- Metastatic malignancy
- Motor neuron disease
- Pulmonary fibrosis
- Solid organ malignancy
- Patients younger than 18 years old are excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description EHR-Based Intervention A EHR-Based Intervention A Intervention A (Prognostication) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. EHR-Based Intervention B EHR-Based Intervention B Intervention B (Accountable Justification) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. Combined EHR-Based Intervention (A+B) EHR-Based Intervention A Intervention A and B prompts will be combined and triggered for eligible patients simultaneously. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner. Combined EHR-Based Intervention (A+B) EHR-Based Intervention B Intervention A and B prompts will be combined and triggered for eligible patients simultaneously. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner.
- Primary Outcome Measures
Name Time Method Composite Measure: Length of Stay and In-Hospital Mortality Duration of hospital stay, an expected average of 16 days The primary outcome is a composite measure of hospital length-of-stay and mortality that ranks deaths along the length-of-stay distribution
- Secondary Outcome Measures
Name Time Method 30-day hospital readmission 30 days 30-day hospital readmission
30-day mortality 30 days Mortality rate at 30 days
Palliative withdrawal of mechanical ventilation Duration of hospital stay, an expected average of 16 days Palliative withdrawal of mechanical ventilation during hospital admission
180-day mortality 180 days Mortality rate at 180 days
Change in code status Duration of hospital stay, an expected average of 16 days Change in documented code status during hospital admission
Initiation of additional forms of life-support Duration of hospital stay, an expected average of 16 days Initiation of additional form of life-support (e.g. surgical feeding tube, dialysis) during hospital admission
Time to palliative care consult Duration of hospital stay, an expected average of 16 days The number of hours from ICU admission to inpatient palliative care consult
Receipt of cardiopulmonary resuscitation (CPR) Duration of hospital stay, an expected average of 16 days CPR prior to death or discharge
ICU mortality Duration of hospital stay, an expected average of 16 days ICU mortality
ICU length of stay Duration of hospital stay, an expected average of 16 days ICU length of stay (hours)
Duration of mechanical ventilation Duration of hospital stay, an expected average of 16 days Hours of mechanical ventilation during hospital admission
Hospital discharge disposition Duration of hospital stay, an expected average of 16 days Hospital discharge disposition to home, hospice, long-term acute care, nursing facility, or rehabilitation
90-day mortality 90 days Mortality rate at 90 days
Palliative care consult Duration of hospital stay, an expected average of 16 days Receipt of palliative care consult during hospital admission
ICU readmission Duration of hospital stay, an expected average of 16 days Readmission to an ICU within the same hospitalization
Time to withdrawal of life-support Duration of hospital stay, an expected average of 16 days The number of hours from trial enrollment to time that comfort-care order is placed
Quality of Dying & Death (1-item) 48-72 hours following an in-hospital death Nurse-reported postmortem rating of a patient's dying experience
90-day hospital readmission 30 days 30-day hospital readmission
180-day hospital readmission 30 days 30-day hospital readmission
Hospital free days 180 days Hospital free days within 180 days
Trial Locations
- Locations (10)
Atrium Health Cleveland
🇺🇸Shelby, North Carolina, United States
Atrium Health Pineville
🇺🇸Charlotte, North Carolina, United States
Carolinas HealthCare System Stanly
🇺🇸Albemarle, North Carolina, United States
Carolinas HealthCare System, NorthEast
🇺🇸Charlotte, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Atrium Health CMC-Mercy
🇺🇸Charlotte, North Carolina, United States
Atrium Health University City
🇺🇸Charlotte, North Carolina, United States
Atrium Health Lincoln
🇺🇸Lincolnton, North Carolina, United States
Atrium Health Union
🇺🇸Monroe, North Carolina, United States
Carolinas HealthCare System Blue Ridge-Morganton
🇺🇸Morganton, North Carolina, United States